Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine Coadministered With Two Attenuated Vaccines
Study Details
Study Description
Brief Summary
Eligible participants were randomly assigned (1:1:1), using block randomization stratified, to either 3 groups. Group 1 will be immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28.
Group 2 will be immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28.
Group 3 will be immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28.
Vaccines were administered 28 days apart, with blood samples taken on day 0 and day 28 before vaccination, and on day 56. Local and systemic symptoms and serious adverse events following immunzation were collected.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group 1 immunized inactivated SARS-CoV-2 vaccine and varicella vaccine in day 0 followed by measles-mumps-rubella vaccine(MMR) in day 28. |
Biological: Inactivated SARS-CoV-2 vaccine coadministered with vricella vaccine
Subjects will be coadministered with inactivated SARS-CoV-2 vaccine and varicella vaccine.
|
| Experimental: Group 2 immunized varicella vaccine in day 0 followed by SARS-CoV-2 vaccine and MMR in day 28. |
Biological: Inactivated SARS-CoV-2 vaccine coadministered with MMR
Subjects will be coadministered with SARS-CoV-2 vaccine and MMR.
|
| Active Comparator: Group 3 immunized inactivated SARS-CoV-2 vaccine in day 0 followed by MMR and varicella vaccine in day 28. |
Biological: Inactivated SARS-CoV-2 vaccine administered alone
Subjects will be immunized with inactivated SARS-CoV-2 vaccine alone
|
Outcome Measures
Primary Outcome Measures
- non-inferiority of the seroconversion rate and neutralising antibody level against SARS-CoV-2 [on day 28 after vaccination]
Neutralizing antibody of SARS-CoV-2 is an index of immunogenicity
- non-inferiority of the seroconversion rate and IgG antibody level against measles, rubella, and mumps [on day 28 after vaccination]
IgG antibodies of measles, rubella, and mumps is an index of immunogenicity
- non-inferiority of the seroconversion rate and IgG antibody level against varicella [on day 28 after vaccination]
IgG antibodies of varicella is an index of immunogenicity
Secondary Outcome Measures
- incidence of reported vaccine-related adverse events within 28 days of each immunization. [from 0 to 28 days after vaccination]
adverse events including local and systemic symptoms followng immunization
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 4 years old
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With legal guardian signing the informed consent
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Able to participate in all planned visits and comply with all research procedures (such as completing diary cards of adverse events and participating visits)
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With clear vaccination records including no SARS-CoV-2 vaccine history, with 1 varicella vaccine and 2 measles-containing vaccines history
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the last attenuated vaccine was administered ≥28 days ago, and other vaccines administered ≥14 days ago
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With an axillary temperature ≤37.5℃ at the time of vaccination
Exclusion Criteria:
First dose exclusion criteria:
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With SARS-CoV-2 infection in the last 3 months (any of the following conditions shall be met: positive nucleic acid test; positive antigen test; suspected SARS-CoV-2 infection symptoms of subject or close contacts)
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allergic to any substance of the vaccine or with a severe allergic reactions history of vaccines (such as acute allergic reactions, angioneurotic edema, breathing difficulties, etc.)
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Suffering uncontrolled epilepsy or progressive nerve system diseases, or with a history of Gribali syndrome
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With acute illness, severe or acute attack of chronic illness or fever
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With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs (oral steroids)
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Received non specific immunoglobulin within 3 months
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Any situation that researchers thought that might influence the consequence of the clinical trial Second dose exclusion criteria：
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Occurrence of any serious adverse event that may be related to the previous dose of study vaccine
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Occurrence of systemic adverse reactions or allergic reactions with a severity level ≥ 3 recognized by researchers after vaccination
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Any new situations that fit the first dose exclusion criteria
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Any situation that researchers thought that might influence the consequence of the clinical trial
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Municipal Center for Disease Control and Prevention | Shanghai | Shanghai | China | 021 |
Sponsors and Collaborators
- Shanghai Municipal Center for Disease Control and Prevention
- China National Biotec Group Company Limited
Investigators
- Study Director: Zhuoying Huang, Shanghai Municipal Center for Disease Control and Prevention
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SH2023-9